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Randomized Controlled Trial
. 2024 Nov;30(11):3303-3309.
doi: 10.1038/s41591-024-03265-3. Epub 2024 Sep 19.

Echocardiographic screening for heart failure and optimization of the care pathway for individuals with pacemakers: a randomized controlled trial

Maria F Paton  1   2 , John Gierula  1 , Haqeel A Jamil  1 , Sam Straw  1 , Judith E Lowry  1 , Rowena Byrom  1 , Thomas A Slater  1 , Alasdair M Fellows  3 , Richard G Gillott  2 , Hemant Chumun  2 , Paul Smith  4 , Richard M Cubbon  1 , Deborah D Stocken  3 , Mark T Kearney  1 , Klaus K Witte  5
Affiliations
Randomized Controlled Trial

Echocardiographic screening for heart failure and optimization of the care pathway for individuals with pacemakers: a randomized controlled trial

Maria F Paton et al. Nat Med. 2024 Nov.

Abstract

Individuals with pacemakers are at increased risk of left ventricular systolic dysfunction (LVSD). Whether screening for and optimizing the medical management of LVSD in these individuals can improve clinical outcomes is unknown. In the present study, in a multicenter controlled trial (OPT-PACE), we randomized 1,201 patients (717 men) with a pacemaker to echocardiography screening or usual care. In the screening arm, LVSD was detected in 201 of 600 (34%) patients, who then received management in either primary care or a specialist heart failure (HF) and devices clinic. The primary outcome of the trial was the difference in a composite of time to first HF hospitalization or death. Over 31 months (interquartile range = 30-40 months), the primary outcome occurred in 106 of 600 (18%) patients receiving echocardiography screening, which was not significantly different compared with the occurrence of the primary outcome in 115 of 601 (19%) patients receiving the usual care (hazard ratio = 0.89; 95% confidence interval = 0.69, 1.17). In a prespecified, nonrandomized, exploratory analysis, patients with LVSD managed by the specialist clinic experienced the primary outcome event less frequently than those managed in primary care. The results of this trial indicate that echocardiography screening commonly identifies LVSD in individuals with pacemakers but alone does not alter outcomes. ClinicalTrials.gov registration: NCT01819662 .

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Conflict of interest statement

Competing interests M.F.P. holds an NIHR clinical post-doctoral fellowship outside of this work. J.G. holds an NIHR post-doctoral fellowship outside of this work. S.S. holds an NIHR academic clinical lectureship outside of this work. R.M.C. held an intermediate fellowship with the British Heart Foundation (BHF). D.D.S. holds an NIHR research professor award outside of this work. M.T.K. holds a BHF chair. K.K.W. held an NIHR clinician scientist award for the duration of the present study (no. NIHR-CS-012-032). The other authors declare no competing interests.

Figures

Fig. 1
Fig. 1. OPT-PACE CONSORT diagram.
Disposition and flow of participants enrolled to OPT-PACE.
Fig. 2
Fig. 2. Time free of all-cause mortality or HFH by randomization group.
Kaplan–Meier curve demonstrating the primary outcome in those allocated screening by echocardiography (intervention) or no screening (standard care).
Fig. 3
Fig. 3. Time free of all-cause mortality or HFH by the clinical management pathway.
Kaplan–Meier curve demonstrating the exploratory analysis of the primary outcome in those allocated screening by echocardiography (intervention) divided by management pathway (primary-care-led management or specialist clinic-led management) or no screening (standard care).
Extended Data Fig. 1
Extended Data Fig. 1. Screening for heart failure and optimizing pathways of care in people with pacemakers: The OPT-PACE randomized controlled trial.
Graphical abstract describing study design, study flow, data collection time points, outcome sources and endpoints.
Extended Data Fig. 2
Extended Data Fig. 2. Time Free of All-Cause Mortality or Heart Failure Hospitalisation According to Prespecified Subgroup.
Forest plot describing the primary outcome by relevant prespecified clinical subgroups showing no difference in primary outcome between those allocated screening by echocardiography and those allocated standard care.
See this image and copyright information in PMC

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